Reduction or Discontinuation of TNF-α Inhibitor in Non-infectious Uveitis Patients

Study of TNF-α Inhibitor Reduction or Discontinuation in Patients With Non-infectious Uveitis

TNF-α inhibitors, like Adalimumab, have good efficacy in non-infectious uveitis, but long-term use can increase the risk of drugs, and the patient's financial burden is large. The objective of this study was to explore the reduction or withdrawal of Adalimumab in uveitis patients with stable drug control, and to evaluate the efficacy and safety of drug reduction in uveitis patients, as well as the impact on their vision prognosis.

Study Overview

• Status: Recruiting
• Conditions: Uveitis; Adalimumab
• Intervention / Treatment: Biological: reduction or discontinuation of Adalimumab

Detailed Description

TNF-α inhibitors, like Adalimumab, have good efficacy in non-infectious uveitis, but long-term use will increase the risk of drugs, and the patient's financial burden is large. Previous studies have reported that tapering or discontinuation of Adalimumab may be considered in patients with stable disease. In clinical practice, some important questions about the feasibility of dose reduction in individual patients and the withdrawal plan remain unanswered. The objective of this study was to explore the reduction or withdrawal of Adalimumab in uveitis patients with stable drug control, and to evaluate the efficacy and safety of drug reduction in uveitis patients, as well as the impact on their vision prognosis.

• Study Type: Interventional
• Enrollment (Anticipated): 28
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Dan Liang, PhD; Phone Number: 0086-20-87330402; Email: liangd2@mail.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Recruiting
      • Zhongshan Ophthalmic Center, Sun Yat-sen University
      • Contact: Dan Liang, PhD; Phone Number: 0086-20-87330402; Email: liangd2@mail.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 70 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Clinical diagnosis of non-infectious uveitis
• nflammation was controlled for 6 months after drug remission was achieved using Adalimumab in combination with immunosuppressant therapy
• Family members and patients who are willing to stop should agree and accept relevant examinations
• The informed consent is read and signed by the patient or a legally authorized represent

Exclusion Criteria:

• Unwilling to sign informed consent
• There is systemic autoimmune disease uncontrolled situation
• Patients who may require surgery in the near future
• Vision meets the standards of low vision and blindness
• Silicone oil or gas filling after vitreous surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Patients with inactive uveitis; Patients with non-infectious uveitis whose inflammation reached remission for at least six months after treatment with Adalimumab	Biological: reduction or discontinuation of Adalimumab; For patients with non-infectious uveitis whose inflammation stabilizes after treated with Adalimumab, extended dosing intervals to once a month, during which inflammatory status is monitored. If there was no recurrence within 6 months, Adalimumab was discontinued, and whether inflammation recurred after withdrawal was observed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
relapse rate of inflammation	The proportion of the number of uveitis relapse patients during the process of reduction or discontinuation	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Best corrected visual Acuity	increase of BCVA	24 months
macular structure	Macular thickness (MT). increase of central foveal thickness	24 months

Collaborators and Investigators

• Sponsor: Dan Liang
• Investigators: Principal Investigator: Dan Liang, PhD, Zhongshan Ophthalmic Center, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2021
• Primary Completion (ANTICIPATED): January 1, 2023
• Study Completion (ANTICIPATED): April 1, 2023

Study Registration Dates

• First Submitted: December 9, 2021
• First Submitted That Met QC Criteria: December 9, 2021
• First Posted (ACTUAL): December 13, 2021

Study Record Updates

• Last Update Posted (ACTUAL): December 13, 2021
• Last Update Submitted That Met QC Criteria: December 9, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Uveitis; Adalimumab; TNF-α inhibitor
• Additional Relevant MeSH Terms: Eye Diseases; Uveal Diseases; Uveitis; Anti-Inflammatory Agents; Antirheumatic Agents; Adalimumab
• Other Study ID Numbers: 2021-ADA-Stop

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No